The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
Subjects will have been recently diagnosed with an untreated solid tumor. Subjects will have
a blood sample collected at enrollment and provide medical history prior to initiation of
treatment. There will be no further follow-up.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||August 23, 2018||Observational|
Primary Outcome 1 - Measure: Biomarker Evaluation
Primary Outcome 1 - Time Frame: Point in time (one day) blood collection at enrollment
1. Subject is male or female > 18 years of age.
2. Subject has an untreated primary malignancy of breast, lung, colorectal, prostate,
bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or<br/> esophageal cancer.
3. Subject understands the study procedures and is able to provide informed consent to
participate in the study and authorization for release of relevant protected health
information to the study Investigator.
1. Any previous cancer diagnosis within the past 5 years (with the exceptions of basal
cell or squamous cell skin cancers).
2. Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample
3. Any treatment for the primary malignancy or sites of metastases. Subject may not have
started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or
other treatment and/or surgery prior to blood sample collection.
4. Less than 3 days between fine needle aspiration (FNA) of target pathology and blood
5. Less than 7 days between biopsy (other than FNA) of target pathology and blood
6. IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
7. Individual has a condition the Investigator believes would interfere with his or her
ability to provide informed consent, comply with the study protocol, which might
confound the interpretation of the study results or put the person at undue risk.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Alexandra Massoud
|CARTI Cancer Center
Little Rock, Arkansas 72205
|Sun Research Institute
San Antonio, Texas 78215
|Seattle Urology Research Center
Burien, Washington 98166